Research feasibility and ethics in Scottish new-born blood spot archive.

Abstract New-born heel prick blood spots are routinely used to screen for inborn errors of metabolism and life-limiting inherited disorders1. The Danish Newborn Screening Biobank (DNSB) has shown that nucleic acid, metabolic and protein assays are feasible on archived new-born dried blood spots2. Denmark is currently the only country in the world where nation-level linkage of such secondary data to health records is approved2. In the new era of health data science and predictive medicine, the potential value of secondary data from new-born blood spot archives merits wider ethical consideration and assessment of feasibility for public benefit. Early life exposures and behaviours set health trajectories in childhood and later life. The new-born blood spot is potentially well placed to create an unbiased and cost-effective population-level retrospective birth cohort study. Scotland has retained new-born blood spots, commonly known as Guthrie cards, for all children born since 1965, around 3 million in total. However, a moratorium on research access is currently in place, pending public consultation. We conducted a Citizens’ Jury, with Jurors delivering an agreed verdict that conditional research access to the Guthrie Cards was in the public interest. The Chief Medical Officer for Scotland authorised restricted lifting of the current research moratorium to allow a feasibility study. In support of a wider public consultation, Guthrie cards from consented Generation Scotland volunteers3,4 were retrieved and their potential for both epidemiological and biological research demonstrated.